SchizophreniaPhase 3NCT06961968
Randomized Withdrawal Study in Patients With Schizophrenia
A Phase 3 study testing iloperidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 22 sites in United States.
Trial summary
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- iloperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 May 2025to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 to 65 years of age (inclusive)
- Diagnosed with schizophrenia per DSM-5 criteria
- In need of ongoing psychiatric treatment
Who cannot join
- DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Vanda Investigational Site
Atlanta, Georgia, 30328
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Austin, Texas, 78754
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Bellevue, Washington, 98007
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Chicago, Illinois, 60641
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Costa Mesa, California, 92626
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Flowood, Mississippi, 39232
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Houston, Texas, 77081
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Irving, Texas, 75062
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Lemon Grove, California, 91945
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Marlton, New Jersey, 08053
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
North Miami, Florida, 33161
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Oceanside, California, 92056
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Peachtree Corners, Georgia, 30071
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Pico Rivera, California, 90660
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Richardson, Texas, 75080
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Rogers, Arkansas, 72758
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Saint Charles, Missouri, 63304
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
San Diego, California, 92123
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
St Louis, Missouri, 63141
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Staten Island, New York, 10314
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Walnut Creek, California, 94596
Vanda Pharmaceuticals, 202-734-3400
About this study
Official title: A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- iloperidone, placebo
- Keywords
- Schizophrenia, Antipsychotic Agents, Iloperidone, Long-Acting Injection, Randomized Withdrawal
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloperidoneDrug
iloperidone LAI
placeboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| iloperidone | Experimental | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks. Receives: Drug: iloperidone |
| placebo | Placebo comparator | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exacerbation of symptoms
As measured by the time to first exacerbation of psychiatric symptoms
Measured: Up to 52 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start14 May 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961968
- Sponsor's protocol ID
- VP-VYV-683-3102
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection
- ClinicalTrials.gov ID
- NCT06961968
- Acronym / sponsor ID
- VP-VYV-683-3102
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic Agents, Iloperidone, Long-Acting Injection, Randomized Withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iloperidone | Experimental | Drug: iloperidoneDuring the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks. |
| placebo | Placebo comparator | Drug: placeboDuring the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females 18 to 65 years of age (inclusive)
- Diagnosed with schizophrenia per DSM-5 criteria
- In need of ongoing psychiatric treatment
Key exclusion criteria (1 listed)
- DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloperidoneiloperidone LAI | Drug | iloperidone |
| placebomatching placebo | Drug | placebo |
Primary outcome
Time to exacerbation of symptoms
Time frame: Up to 52 weeks post-randomization
As measured by the time to first exacerbation of psychiatric symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iloperidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals Inc. (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exacerbation of symptoms (time frame: Up to 52 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.